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Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination

NCT00442130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-09-17

No results posted yet for this study

Summary

The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.

Conditions

Interventions

BIOLOGICAL

GM-K562 vaccine

The vaccine will be administered over 1 cycle of 7 weeks, that begins 1 month after stem cell transplant. The vaccine will be given 6 times over 2 months -- once a week for three weeks then every other week for 3 vaccines.

PROCEDURE

stem cell transplantation

Participants will be admitted to the hospital for approximately 8 days to receive chemotherapy and stem cell transplantation

Sponsors & Collaborators

Principal Investigators

  • Catherine J. Wu, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2014-02-28
Completion
2020-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442130 on ClinicalTrials.gov